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临床试验/NCT01398631
NCT01398631已完成不适用

A Prospective Comparison of the TIMI, GRACE and HEART Scores for Predicting Cardiovascular Events in Chest Pain Patients in the Emergency Room

R&D Cardiologie9 个研究点 分布在 1 个国家目标入组 2,440 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,440
试验地点
9
主要终点
Occurence of MACE (Major Adverse Cardiac Events)

研究概览

简要总结

Various elements of patient history are checked and entered in the admission Case Recor Form (CRF). Three risk scores are calculated out of these elements, combined with physical examination, laboratory values and ECG-findings.

The primary aim is to assess the positive and negative predictive values for a cardiovascular event of the three risk scores for chest pain patients.

Secondary aim is to assess the sensitivity and specificity of various elements in the patient history for an acute coronary syndrome.

详细描述

This is a prospective, observational study in patients admitted to the emergency room for chest pain. All patients are checked by the resident in charge immediately on admission, before any lab values are known, by means of an admission Case Report Form (CRF), consisting of classical elements of patient history, risk factors, medication and physical examination. This CRF is filled out immediately by the resident. No additional effort will be asked of the patients.

Patient data during a follow up of at least 6 weeks are gathered from hospital charts.

The predictive value of the three scoring systems: HEART (History, ECG, Age, Risk factors, Troponin), TIMI (Thrombolysis in Myocardial Infarction) and GRACE (Global Registry of Acute Coronary Events) for both the discharge diagnosis and the occurrence of Major Adverse Cardiovascular Events (MACE) is calculated.

The primary hypothesis of the study is that the HEART score is a significantly better predictor than the TIMI and/or GRACE score for cardiovascular events during a six week period following admission to the emergency room.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • any patient visiting the cardiology emergency room due to chest pain

排除标准

  • chest pain clearly due to rhythm disturbances or acute heart failure
  • concomitant non cardiac disease with expected fatal outcome within 1 year

结局指标

主要结局

Occurence of MACE (Major Adverse Cardiac Events)

时间窗: 6 weeks after presentation

The number of patients diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)

次要结局

  • The number of patients undergoing Coronary ArterioGraphy (CAG)(Three months after presentation)
  • The number of patients suffering Acute Coronary Syndrome (ACS)(3 months after presentation)

研究者

发起方
R&D Cardiologie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbra Backus

MD, PhD

R&D Cardiologie

研究点 (9)

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